Data from a phase 2b clinical trial1 showed promise for a new topical pan-Janus kinase (JAK) inhibitor for the treatment of chronic hand eczema. The findings were presented at the virtual European Academy of Dermatology and Venerology Congress.
The randomized, double-blind, vehicle-controlled, parallel group study included 258 participants with atopic dermatitis who were randomized 1:1:1:1:1 to delgocitinib 1-, 3-, 8-, or 20-mg cream or vehicle twice daily for 16 weeks. Primary and second endpoints included the proportion of participants who achieved an Investigator Global Assessment for Chronic Hand Eczema score of 0 (clear) or 1 (almost clear) with an improvement of 2 or greater from baseline at week 16 and changes in the Hand Eczema Severity Index (HESCI) from baseline to week 16.
Overall, the researchers found more participants in the 8- and 20-mg groups had achieved the primary endpoint compared with those in the vehicle group (36.5% vs 37.5% vs 8%, respectively). While all delgocitinib groups showed statistically significant improvements in HESCI scores from baseline to week 16 compared with the vehicle group, earlier improvements were observed in the 8- and 20-mg groups. These statistically significant improvements were seen by week 4 in the 8-mg group and week 6 in the 20-mg group.
Furthermore, the researchers did not observe any dose-related adverse effects, and the majority of adverse effects were mild or moderate in severity. The most commonly reported adverse effects were nasopharyngitis, eczema, and headache.
In an interview with Autoimmune Learning Network, corresponding author Margitta Worm, MD, professor of dermatology with the Division of Allergy and Immunology at Charité-Universitätsmedizin in Berlin, Germany, discussed these findings.
AUTOIMMUNE LEARNING NETWORK: Could you briefly discuss the mechanisms of action for delgocitinib?
Dr Worm: In chronic hand eczema, there is an ongoing chronic inflammatory process, and this chronic inflammation is triggered by mediators called cytokines. Cytokine production is controlled via JAKs.
Delgocitinib is a pan‑JAK inhibitor, meaning that it interferes with the production of those cytokines, so there is less production and therefore less inflammation. In addition, delgocitinib has a broader anti-inflammatory approach because it is a pan-JAK inhibitor.